MAUDE Adverse Event Report: PENTRON CLINICAL SIMILE; TOOTH SHADE RESIN MATERIAL

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor's office alleged that five (5) patients had experienced their restorations being too light after placement with simile and flow-it products.This is the fourth of five (5) reports.

Manufacturer Narrative

Patient's specifics with regard to gender, age and weight were not provided by the doctor.The doctor replaced the restoration for the patient using a darker shade, without further incident.To date, the patient is doing fine.The product alleged in this incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.

• Brand Name: SIMILE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): PENTRON; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 4006577
• MDR Text Key: 16303945
• Report Number: 2024312-2014-00563
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FLOW IT
• Patient Outcome(s): Other; Required Intervention